March 6, 2023
Grifols enters into global collaboration and licensing agreement with Selagine to develop immunoglobulin eye drops to treat dry eye disease
- First-ever ocular surface indication for a Grifols immunoglobulin (Ig) would potentially provide a much-needed treatment for dry eye disease (DED), a condition affecting more than 100 million people globally
- Under the terms of the agreement, Grifols to have worldwide exclusive commercial rights to Selagine’s treatment upon regulatory authorization, expected in early 2029
- A clinical development program will determine the efficacy and tolerability of Grifols Ig eye drops as an anti-inflammatory agent to treat both signs and symptoms of DED
- Grifols reinforces its innovation ecosystem through organic development and strategic alliances to accelerate its pipeline and provide breakthrough therapies while driving sustainable business growth and profitability
Barcelona, Spain, March 6, 2023 – Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced a global collaboration and licensing agreement with Selagine Inc, a company focused on developing novel therapeutics for ocular diseases, to treat dry eye disease (DED) with immunoglobulin eye drops.
The potential Ig treatment, once it completed clinical development and received regulatory authorizations, would become Grifols’ first ocular-surface indicated medicine as well as the company’s first-ever product for DED, which affects more than 100 million people globally.
Under their agreement, Grifols will have worldwide exclusive commercial rights to Selagine’s treatment, which will be developed combining Grifols’ expertise in developing and manufacturing innovative Ig therapies as well as Selagine’s cutting-edge research, medical expertise and clinical experience treating debilitating eye diseases. A new product is expected to reach retail pharmacies following regulatory authorization in early 2029.
In a pilot phase I/II clinical trial, Selagine treated subjects with eye drops based on Grifols Flebogamma DIF® twice daily for eight weeks and secured a significant reduction in the signs and symptoms of DED, and with no difference in tolerability or adverse events.
Several different sources of inflammation, including proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells) and pathogenic antibodies, are present on the ocular surface in DED and contribute to its signs and symptoms. Selagine’s line of research is that the broad-spectrum anti-inflammatory actions of an ocular surface immunoglobulin are superior to currently approved therapies, which are narrow spectrum and limited mainly to targeting T-cell inflammatory mechanism.
According to the agreement, Grifols will fund the entire clinical development program through approval by the U.S. Food and Drug Administration, which will be managed jointly by both companies. This includes the clinical, manufacturing and regulatory activities required for FDA approval for an indication for dry eye disease. Grifols would sub-license the potential treatment and make tiered royalty payments based on net sales as well as milestone payments upon achievement of certain annual sales thresholds.
Grifols continues to innovate and drive long-term strategic business growth through organic initiatives and strategic collaborations such as Selagine.
“Grifols is very excited to combine our synergistic strengths with Selagine in a potentially game-changing treatment for an unmet medical need that can help millions of patients globally with dry eye disease,” said Victor Grifols Deu, co-CEO of Grifols. “We are committed to maximizing our deep and ever-growing knowledge of immunoglobulins to treat the broadest range of therapeutic areas.”
“Selagine and Grifols have an exceptional opportunity to change the paradigm of dry eye treatment through a novel approach that has the potential to significantly improve the quality of life of patients suffering from this condition,” said Dr. Sandeep Jain, MD, founder and President of Selagine and BA Field Professor of Ophthalmology at the University of Illinois Chicago.
About Dry Eye Disease
It is a common and chronic multifactorial inflammatory disease characterized by insufficient moisture in the outer surface of the eye, leading to dryness, pain, discomfort, diminished quality of life and, in severe cases, permanent vision impairment. Currently approved treatments, such as artificial tears and anti-inflammatories (corticosteroid therapy, cyclosporine therapy and lifitegrast), may take weeks or even months to demonstrate activity.